MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; C.A.P. HD DUODENOSCOPE (US)

Model Number	ED34-I10T
Medical Device Problem Code	Break (1069)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The time of event is unknown.There was no report of patient harm.Video image failure(objective lens broken).
Additional Manufacturer Narrative
We checked the returned unit and confirmed that the objective prism was broken.Based on the result, we concluded that it was caused due to the excessive force applied on the objective prism.In addition, we confirmed that the lcb distal cover glass cracked, and the operation channel resistance; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report and/or the risk analysis results, it was evaluated to submit mdr.

• Brand Name: PENTAX
• Common Device Name: C.A.P. HD DUODENOSCOPE (US)
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645
• MDR Report Key: 13767997
• Report Number: 9610877-2022-51596
• Device Sequence Number: 17169870
• Product Code: FDT
• UDI-Device Identifier: 04961333232956
• UDI-Public: 04961333232956
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K163614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2022

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ED34-I10T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No